This invention relates to a closure for sealing a port of a container. In particular, the present invention relates to a tamper evident closure for hermetically sealing a port of a container.
Ports are utilized to provide a means of accessing material packaged within a container. As used herein, the term ports includes, without limitation, fitments, valves, and other means for accessing a container. Typically, the ports comprise a tubular structure with an inner bore. Located within the inner bore is a needle pierceable wall which provides a barrier between the fluid contained within the container and the outside environment. Usually a pointed means that pierces the pierceable wall is utilized to access the fluid and container. In the medical industry, parenteral and peritoneal dialysis solutions are packaged in flexible containers that are accessed through ports. An example of a flexible container utilized for parenteral solutions is the VIAFLEX.RTM. collapsible plastic container sold by Travenol Laboratories, Inc. of Deerfield, Ill.
Particularly in the medical industry where these solutions are intended for intrabody administration, and in other applications, the solutions must be maintained in a sterile condition. In order to avoid introducing harmful agents into the body, it is essential that the solutions are maintained and extracted under sterile conditions. This requires not only that the container and its contents be in a sterile sealed condition at the time of receipt by the user, but also that no contamination to the contents occur when the container is opened by the physician or nurse prior to use. The problem of maintaining sterility is particularly acute at the port of the container. Any contamination that accumulates on the port may be introduced into the solution when the container is accessed.
To ensure an aseptic environment it is therefore necessary that the opening of the tubular bore of the port is sealed prior to use. Typically, the port is sealed by a closure. The closure should hermetically seal the port, remain affixed to the port during transit, and not be overly difficult to remove. Usually a doctor, nurse or other user of the container who must access the port, must be able to remove the closure with one hand. It is also advantageous if the closure provides a method of determining if the hermetic seal between the closure and the port has been broken. Providing a tamper evident closure is hampered by the fact that the closure should not be overly difficult to open. The prior art closures have not been entirely satisfactory in providing a hermetically sealed tamper resistant closure.
Because it is often necessary to utilize the solution contained in the container in an expedited manner, and in view of the fact that a misidentification can result in severe complications in the patient, it is advantageous if the container can be identified quickly. One way to accomplish this is to color code the closure. A disadvantage of color coding the closure is that once the closure is removed the container is no longer color coded.
Thus, it is a purpose of the present invention to overcome the disadvantages of the prior art.